Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 4:52 AM
Study NCT ID:
NCT05484232
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-02', 'releaseDate': '2024-02-07'}], 'estimatedResultsFirstSubmitDate': '2024-02-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2022-07-31', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of surgery ,', 'timeFrame': 'Intraoperative', 'description': 'compare between duration of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy'}, {'measure': 'percentage of complications', 'timeFrame': '6 months', 'description': 'compare between percentage of complications of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy'}, {'measure': 'morbidity', 'timeFrame': '6 months', 'description': 'compare morbidity between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy'}, {'measure': 'mortality', 'timeFrame': '6 months', 'description': 'compare mortality between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Calculous Cholecystitis']}, 'referencesModule': {'references': [{'pmid': '24020050', 'type': 'BACKGROUND', 'citation': 'Gul R, Dar RA, Sheikh RA, Salroo NA, Matoo AR, Wani SH. Comparison of early and delayed laparoscopic cholecystectomy for acute cholecystitis: experience from a single center. N Am J Med Sci. 2013 Jul;5(7):414-8. doi: 10.4103/1947-2714.115783.'}, {'pmid': '24444271', 'type': 'BACKGROUND', 'citation': 'Ozkardes AB, Tokac M, Dumlu EG, Bozkurt B, Ciftci AB, Yetisir F, Kilic M. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective, randomized study. Int Surg. 2014 Jan-Feb;99(1):56-61. doi: 10.9738/INTSURG-D-13-00068.1.'}, {'pmid': '25749854', 'type': 'BACKGROUND', 'citation': 'Cao AM, Eslick GD, Cox MR. Early Cholecystectomy Is Superior to Delayed Cholecystectomy for Acute Cholecystitis: a Meta-analysis. J Gastrointest Surg. 2015 May;19(5):848-57. doi: 10.1007/s11605-015-2747-x. Epub 2015 Mar 7.'}, {'pmid': '25535191', 'type': 'BACKGROUND', 'citation': 'Minutolo V, Licciardello A, Arena M, Nicosia A, Di Stefano B, Cali G, Arena G. Laparoscopic cholecystectomy in the treatment of acute cholecystitis: comparison of outcomes and costs between early and delayed cholecystectomy. Eur Rev Med Pharmacol Sci. 2014 Dec;18(2 Suppl):40-6.'}]}, 'descriptionModule': {'briefSummary': 'Laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. The initial treatment of acute calculus cholecystitis includes GIT rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. Following this treatment, patients with uncomplicated disease are managed on outpatient basis and are called for elective laparoscopic cholecystectomy after a period of 6-8 weeks.\n\nElective laparoscopic cholecystectomy has become the gold standard for treatment of symptomatic gallstones. However, in the early days, acute cholecystitis was a contraindication of laparoscopic cholecystectomy, and patients with acute cholecystitis were managed conservatively and discharged for re-admission in order to have elective surgery performed for the definitive treatment.\n\nEarly laparoscopic cholecystectomy, within 72 hours of presentation,has been advocated because of shorter hospital stay, decreased financial costs and reduced readmission rates. Previously cited reasons against early laparoscopic cholecystectomy include the increased technical difficulties, increased risk of conversion to an open procedure (6-35 % in some studies) and increased risks of biliary complications such as bile leaks and common bile duct (CBD) injuries when operating on an inflamed gallbladder with edematous planes and distorted anatomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient presented by Acute cholecystitis fit for lap cholecystectomy .\n\nExclusion Criteria:\n\n* Patients unfit for laparoscopic surgery such as patients with significant medical illness (ASAgrade more 3), pancreatitis and common bile duct stones'}, 'identificationModule': {'nctId': 'NCT05484232', 'briefTitle': 'Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis', 'orgStudyIdInfo': {'id': 'Soh-Med-22-07-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'description': 'Early laparoscopic cholecystectomy in patients with acute calcular cholecystitis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Osama R Elshrif, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'sherif A Ahmed, resident', 'role': 'CONTACT', 'email': 'shreif011109@med.sohag.edu.eg', 'phone': '01094995035'}, {'name': 'Ahmed e Ahmed, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at general surgery department at sohag university', 'investigatorFullName': 'Sherif Ali Ahmed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-07', 'type': 'RELEASE'}, {'date': '2024-08-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sherif Ali Ahmed, resident doctor at general surgery department at sohag university, Sohag University'}}}}